MEDTRONIC PS MEDICAL STRATA TYPE VALUE— 510(k) K060681

Clearance details

Applicant

Medtronic Neurosurgery

Product code

Code JXG

Device class

Class 2

Regulation

21 CFR 882.5550

Advisory panel

Neurology

Date received

2006-03-15

Decision date

2006-09-15

Decision

Substantially Equivalent

Clearance type

Special

Location

Goleta, CA, US

• K261004 — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) +1 more2026-06-23
• K251598 — Intellidrop2025-12-10
• K250636 — Sophy Mini Monopressure Valve (SM1)2025-11-28
• K252514 — EVAC-MRI2025-11-05
• K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology2025-08-08

• K243676 — Duet External Drainage and Monitoring System (EDMS)2025-03-10
• K242034 — Duet External Drainage and Monitoring System (EDMS)2024-10-24
• K212641 — StrataMR II Valves and Shunts2021-09-16
• K181622 — StrataMR guider tool2018-10-01
• K161370 — Durepair Dura Regeneration Matrix2016-11-02

Death

76

Injury

5,632

Malfunction

2,230

Other

4

Total

7,942

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1116-2021 — Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 27814 STRATA II ASSY SML, 27815 - SHUNT 27815 STRATA II ASSY REG, 27816 - SHUNT 27816 SNAP STRATA II SMALL, 27817 - SHUNT 27817 SNAP STRATA II REG, 27818 - SHUNT 27818 STRATA II SML BIO, 27819 - SHUNT 27819 STRATA II REG BIO, 27823 - SHUNT 27823 STRATA II ASSY SNP REG BIO, 27827 - VALVE 27827 STRATA II REG EXTRACTED, 27888 - SHNT 27888 STRATA II SNAP ASSY REG PCATH, 42335 - VALVE 42335 STRATA NSC BURR HOLE, 42355 - VALVE 42355 FP STRATA NSC SMALL, 42365 - VALVE 42365 FP STRATA NSC REGULAR, 42836 - VALVE 42836 STRATA II BURR HOLE, 42856 - VALVE 42856 FP-STRATA 2 SMALL, 42866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 44420 - SHUNT 44420 STRATA KIT NSC LP, 44421 - KIT 44421 STRATA NSC LP OPEN LUMBAR, 44430 - SHUNT 44430 STRATA KIT NSC LP ASSY, 44465 - VALVE 44465 STRATA NSC LP, 46636 - SHUNT 46636 STRATA NSC BURR, 46655 - ASSY 46655 FP SHUNT STRATA NSC SMALL, 46665 - ASSY 46665 FP SHUNT STRATA NSC REG, 46837 - SHUNT 46837 STRATA II BURR HOLE, 46856 - ASSY 46856 FP-STRATA 2 SHUNT SML, 46866 - ASSY 46866 FP-STRATA 2 SHUNT REG, 92355 - VALVE 92355 STRATA NSC SML BIOGLIDE, 92856 - VALVE 92856 FP STRATA 2 SML BG, 92866 - VALVE 92866 FP STRATA 2 REG BG,Class II·Ongoing·Medtronic Neurosurgery·20210111
• Z-1121-2017 — Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism. Strata Valve Magnet Reverse Polarity (Excludes StrataMR). Catalog No. 27739 27740 27786 27787 27788 27789 27794 27812 27814 27815 27816 27817 27818 27820 27821 27822 27823 27824 27825 27827 27828 27830 27831 27832 27848 27864 27867 27868 27888 27903 27922 27823 27924 23042 27925 27926 27927 27932 27933 42335 42355 42365 42836 42856 42866 44420 44421 44430 44465 46070 46075 46080 46085 46635 46655 46665 46836 46856 46866 46871 46876 46881 46886 92355 92365 92856 92866 96655 96665Class II·Terminated·Medtronic Neurosurgery·20170117

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060681.